Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
研究概览
简要总结
To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.
The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior to study specific examinations the patient has to give his/her written informed consent.
- •Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP).
- •Negative skin prick-test to DP
- •Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP>0.35 kU/L
- •If applicable negative urine pregnancy test and willingness to use effective form of contraception for the duration of involvement in the study.
排除标准
- •Severe immunopathological or immunodeficiencies diseases.
- •Treatment with beta-blockers, even when administered topically
- •Severe psychological disorders
- •Severe Atopic Dermatitis
- •FEV1 <70% predicted after appropriate pharmacological treatment
- •History of hypersensitivity or intolerance to excipients and / or trial medication or other medication to be used for protocol
- •Inability to adequately perform diagnostic tests or treatment
- •Awareness of other inhaled allergens (perennial or seasonal) clinically relevant to the subject and that may interfere with the response evaluation
- •Treatment with immunotherapy in the 5 years prior to his inclusion in the study
结局指标
主要结局
Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
时间窗: Baseline, month 1,3,6,12,18, and 24
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
次要结局
- Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months(Baseline, month 1,3,6,12,18, and 24)
- Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months(Baseline, month 1,3,6,12,18 and 24)
- Change from Baseline response to intradermal test at 1,3,6,12 and 24 months(Baseline, month 1,3,6,12,18, and 24)
- Adverse event(2 years)
- Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months(Baseline, month 1,3,6,12,18, and 24)
- Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months(Baseline, month 1,3,6,12,18 and 24)
研究者
Miguel Blanca Gomez
MD
Plaza del Hospital Civil